Project Synergy: A Clinical Trial to Validate the Synergy Online System

The Synergy Online System (Synergy) is a customisable digital toolkit to assist assessment, monitoring and management of mental health issues and maintenance of wellbeing. It does this by collecting personal and health information (data) from consumers and their service providers. This information is stored, analysed, and reported back to consumers and their health professionals to promote collaborative care partnerships. The clinical content is determined by the service provider who invited the consumer to use Synergy. Synergy does not itself provide stand-alone medical or health advice, diagnosis or treatment. Instead, Synergy guides and supports (but does not direct) consumers and their treating health professionals to decide what may be suitable care options. Importantly, all care aligns with the existing clinical governance (e.g. policies and procedures) of the service provider. The primary objective of this clinical trial is to validate, by provision of objective evidence, that Synergy can be implemented consistently and conforms to all user’s needs and intended uses as it pertains to "stage-based stepped-care". Objective evidence for validation will be collected from Synergy, health professionals assessing consumers, in-service multi-disciplinary teams as well as an independent expert-clinician reference group. This data will be used for: Scientific validity – showing the association of Synergy output to the prevention, early intervention, treatment and continuous monitoring of mental ill health and maintenance of wellbeing using "stage-based stepped-care"; Clinical performance – showing the ability of Synergy to yield a clinically meaningful output for individual users, health professionals and services associated to the target use of Synergy for the purposes of prevention, early intervention, treatment and continuous monitoring of mental ill health and maintenance of wellbeing; and Analytical validity – showing the technical performance of Synergy related to the accuracy, reliability, repeatability and reproducibility of data and recommendations. To conduct this clinical trial, Synergy will be implemented into traditional and online Australian mental health services (participating centres) to use as standard practice for a period of up to 12 months. After contacting a service for care, a consumer will be invited to use Synergy by the service. Following consent, the consumer will complete an immediate online self-report assessment (including demographics, medical and psychological history, current symptoms and functioning) and then view a dashboard of results with recommended care options that are self-managed (eg. apps, etools, fact sheets) or health professional supported (eg. psychological therapies). After the initial assessment and most commonly during the first face-to-face appointment, treating health professionals will review and interact with a consumers dashboard of results and recommended care options. They will also input data regarding the consumer’s overall health, severity of illness, observed levels of distress, function and risk. Importantly, Synergy will provide a recommendation of “staged-based stepped care” and the health professional as well as in-service multi-disciplinary team will provide their consensus to this recommendation. Separately, an independent expert-clinician reference group will review approximately 10% of the results to further validate “staged-based stepped care”.